From bewilderment of patients to the outrage of pharmaceutical companies threatening to drag the government to court, the March 12 notification banning 337 combination of drugs has caused a flutter in the country. However, the ban is neither sudden nor irrational as many would have us believe. It is in fact, the logical conclusion of a long pending demand of the votaries of rational use of drugs for a ban on Fixed-Dose Combinations (FDCs), some of which have been approved by state drug administrations without a clearance from the Centre and have little therapeutic justification.
Among the commonly used brands that are to be banned, after the notification are cough syrups phensedyl and corex, the popular and widely advertised cold medicine Vicks Action 500 – since have been taken off the shelves; antibiotic combination Zimnic AZ and a host of other combination drugs involving commonly used medications like paracetamol, aceclofenac, nimesulide, amoxycillin sildenafil, atorvastatin among others. You can read the full list of the banned combination drugs, here.
FDCs are medicines in which two or more active pharmaceutical ingredients (APIs) are combined in a fixed dose medicine to form a single drug. Side-effects of the combined product and its effects are different from those of its individual components and sometimes the combination can come fraught with risks that are not there in the components by themselves. The added danger is that when an adverse reaction happens in a patient, it is often difficult to place which ingredient is responsible for that reaction. In many cases the combination was merely a way to stump competition rather than a decision with a sound medical basis.
For example, a study published in the Indian Journal of Pharmacology in 2010 found “Nimesulide and paracetamol combination offers no advantage over nimesulide alone or paracetamol alone, either in terms of degree of analgesia or onset of action. Therefore, our study supports the reports claiming irrationality of the fixed dose combination of nimesulide and paracetamol.” The combination stands banned by the recent notification.
The first editorial on the need to crack down on FDCs appeared in the Monthly Index of Medical Specialties in January 1982. The original report of the Kokate Committee too made the same claim as did the organisation, Social Jurist, when it filed a case in Delhi High Court asking for the Nimesulide-paracetamol combination to be banned. In that case, the drug controller general of India had told the court that there is nothing wrong with the said medicine.
The Parliamentary standing committee on health and family welfare, in its 59th report on the functioning of the Central Drugs and Standards Control Authority tabled in May 2012, pointed out several loopholes in the approvals of FDCs and that many of these already stood banned in western countries.
“The Committee is of the view that those unauthorized FDCs, that pose risk to patients and communities such as a combination of two antibacterials need to be withdrawn immediately due to danger of developing resistance that affects the entire population. The Committee is of the view that Section 26A is adequate to deal with the problem of irrational and/or FDCs not cleared by CDSCO. There is a need to make the process of approving and banning FDCs more transparent and fair. In general, if an FDC is not approved anywhere in the world, it may not be cleared for use in India unless there is a specific disease or disorder prevalent in India, or a very specific reason backed by scientific evidence and irrefutable data applicable specifically to India that justifies the approval of a particular FDC. The Committee strongly recommends that a clear, transparent policy may be framed for approving FDCs based on scientific principles,” the committee observed.